CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Phase 1

Recruiting

• Conditions: Leukemia, B-cell
• Interventions: Biological: CART-19/22

• Registration Number: NCT03614858
• Lead Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Brief Summary

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Detailed Description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-07-28
• Study First Submitted QC: 2018-07-28
• Study First Posted: 2018-08-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to <2 year). The study will enroll 20 evaluable patients as follows:
• Age 6-65 years.
• Left ventricular ejection fractions≥ 0.5 by echocardiography.
• Creatinine < 1.6 mg/dL.
• Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal.
• Bilirubin <2.0 mg/dL.
• Karnofsky performance status ≥ 60
• Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria

• Pregnant or lactating women.
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• HIV infection.
• Patients with history of seizure
• Active central nervous system leukemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	CART-19/22	Experimental: Cohort 1 Intervention: Biological: CART-19/22 This cohort will determine the safety and efficacy of targeted CD19/CD22 chimeric Antigen Receptor Engineered T Cell Immunotherapy (CART) in the Treatment of CD19/CD22 Positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V4.03

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China